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Alembic Pharmaceuticals receives FDA approval for hypertension tablets

alembicAlembic Pharmaceuticals Ltd said it received approval from the United States Food & Drug Administration for its abbreviated new drug application for Telmisartan and Amlodipine tablets for hypertension.

The Telmisartan and Amlodipine Tablets are equivalent to the Twynsta tablets of Boehringer Ingelheim Pharmaceuticals, Inc.

An Abbreviated New Drug Application (ANDA) is an application for a U.S. generic drug approval for an existing licensed medication or approved drug.

Telmisartan and Amlodipine Tablets are indicated for the treatment of hypertension, alone or with other antihypertensive agents to reduce blood pressure.

The United States Food and Drug Administration is a federal agency of the United States Department of Health and Human Services, one of the United States federal executive departments.

The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs, etc.

Alembic now has a total of 50 ANDA approvals (44 final approvals and 6 tentative approvals) from USFDA.

Alembic Pharmaceuticals Ltd, established in 1907, is an Indian pharmaceutical company.

The Company is engaged developing formulations and active pharmaceutical ingredients (API).

The Company offers international and domestic formulations. Under domestic formulation, it offers Branded Formulations and Generic formulations.

Alembic’s manufacturing facilities are located in Vadodara and Baddi in Himachal Pradesh.

The plant at Vadodara has the largest fermentation capacity in India. The Panelav facility houses the API and formulation manufacturing plants. The plant at Baddi, Himachal Pradesh manufactures formulations for the domestic and non-regulated export market.

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